Asthma MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Rocaltrol Capsules 0.25mcg
Product Name: Rocaltrol Capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CALCITRIOL
CAS Number: 32222063
Concentration unit: µg microgram(s)
Conc
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female adults aged between 18 to 75 years. 2. Documented history and typical symptoms of asthma for = 6 months prior to screening. 3. Pre-bronchodilator FEV1 20%. 4. Corticosteroid refractory asthma, as defined by a =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Past or present disease, which, as judged by the investigator, may affect the study outcome (other than asthma, rhinitis or eczema). 2. Serum corrected calcium >2.66mmol/L 3. Clinically significant deviation from normal (physical examination or laboratory parameters) as judged by the investigator at the screening visit. 4. Current smoker or an ex-smoker of less than 5 years with a greater than 5 pack year history. 5. Pregnant or lactating females or those at risk of pregnancy (women of childbearing age may be offered a pregnancy test prior to recruitment). 6. History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks of the screening visit requiring oral corticosteroid tablets. 7. Participation in a study involving an investigational medicinal product in the previous 3 months or blood donation within the last year. 8. Current or previous allergen immunotherapy. 9. Concomitant treatment with lithium carbonate or calcium supplements. Thiazide diuretics are a contraindication if the participant is taking calcium supplements at the same time. 10. Inability to understand or comply with the research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our main objective is to investigate whether administration of 1-alpha,25-dihydroxyvitamin D3 enhances the clinical response to orally administered corticosteroids in corticosteroid refractory patients with moderate to severe asthma. The primary outcome measure will be changes in lung function (FEV1).;Secondary Objective: To determine whether there is a correlation between clinical outcome and immunological biomarkers, namely T cell production of IL-10. IL-10 has anti-inflammatory actions in asthma. We hypothesise that adding vitamin D to systemic steroid treatment enhances induction of IL-10 secreting T-cells. ;Primary end point(s): The primary outcome measure is the change in FEV1 at baseline compared to the end of the treatment period.;Timepoint(s) of evaluation of this end point: This will be assessed after unblinding of the trial, when the recruitment will officially finish. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. level of the ex-vivo production of IL-10 and other surrogate biomarkers of outcome or drug effects/process by T-cells. 2. Serological markers of inflammation 3. Fraction of nitric oxide in exhaled air 4. ACQ score ;Timepoint(s) of evaluation of this end point: These will also be assessed after unblinding of the trial, when the recruitment will officially finish. | — |
Countries
United Kingdom
Contacts
Public ContactDr Alexandra Nanzer
Department of Asthma, Allergy and Respiratory Medicine
Outcome results
None listed